Evaluation of impurities in simvastatin drug products with the use of FT-IR spectroscopy and selected chemometric techniques

• Authors: Bogumiła Kupcewicz , Joanna Ronowicz , Grażyna Balcerowska-Czerniak , Andrzej Walasek , Elżbieta Budzisz
• Languages of publication: EN

Abstracts

EN

In the present study a reversed phase high performance liquid chromatography (RP-HPLC) method with diode array detector (DAD) at room temperature was used for obtaining impurity profiles of 20 drug products containing simvastatin as an active substance. Fourier-transform infrared spectroscopy (FT-IR) was carried out to obtain absorption spectra of samples. The partial least squares (PLS) model was built to predict the relative content of lovastatin, the main impurity of simvastatin, and sum of statin-like impurities. In order to build the PLS model, peak areas obtained from HPLC chromatograms were related to FT-IR spectra of drugs. The PLS model based on signal normal variate and orthogonal signal correction (SNV+OSC) transformed FT-IR spectra was able to predict the content of drug impurities in real samples with a good prediction ability (R2 > 0.95). [...]

Keywords

EN

Chemometrics; High Performance Liquid Chromatography; Impurity profiling; Infrared Spectroscopy

• Publisher: De Gruyter Open
• Journal: Open Chemistry
• Year: 2013
• Volume: 11
• Issue: 8
• Pages: 1320-1329

Dates

published

1 - 8 - 2013

online

1 - 6 - 2013

Contributors

author

Bogumiła Kupcewicz

• Department of Inorganic and Analytical Chemistry, Faculty of Pharmacy, Collegium Medicum, Nicolaus Copernicus University, 85-094, Bydgoszcz, Poland

author

Joanna Ronowicz

• Department of Inorganic and Analytical Chemistry, Faculty of Pharmacy, Collegium Medicum, Nicolaus Copernicus University, 85-094, Bydgoszcz, Poland

author

Grażyna Balcerowska-Czerniak

• Institute of Mathematics and Physics, University of Technology and Life Sciences, 85-796, Bydgoszcz, Poland

author

Andrzej Walasek

• Department of Inorganic and Analytical Chemistry, Faculty of Pharmacy, Collegium Medicum, Nicolaus Copernicus University, 85-094, Bydgoszcz, Poland

author

Elżbieta Budzisz

• Department of Inorganic and Analytical Chemistry, Faculty of Pharmacy, Collegium Medicum, Nicolaus Copernicus University, 85-094, Bydgoszcz, Poland

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Identifiers

DOI

10.2478/s11532-013-0264-x